Pharmacovigilance Manager

Role Objective : - The role focuses on ensuring the safety and effectiveness of pharmaceuticals through signal detection, risk management, and regulatory compliance, including preparing and reviewing RMPs, aggregate reports, and signal detection reports. Additionally, the role involves training, SOP / WI authoring, and ensuring compliance with Good Pharmacovigilance Practices. Key Responsibilities :

• Signal Detection and management. Drafting or reviewing signal detection reports.
• To Prepare / Review Risk Management Plan (RMP)
• To Prepare / Review Risk Management Plan aggregate reports (PADERs / PSURs)
• Handling of additional Risk Minimization Measures (aRMM) activities
• Preparing signal and aggregate report schedules
• To ensure that all Pharmacovigilance activities are conducted in accordance with SOP’s, Work Instructions, Good Pharmacovigilance Practices, Good Clinical Practice guidelines and regulatory requirements.
• Training on signal and aggregate activities to team members, CPL employees and new employee.
• Authoring / Review of SOPs and WIs as per requirement.
• Any other actions and responsibilities as agreed with Management
• Preparation of line listing for signal and aggregate reports.

Kindly share resumes on mahek.chandnani@cadilapharma.com